Functional Capacity Through HRV in Multimodal Rehabilitation for Adult Surgery

NCT ID: NCT06436417

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-31

Brief Summary

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This prospective, observational cohort study investigates heart rate variability (HRV) monitoring using the Analgesia Nociception Index (ANI) monitor in adult patients undergoing major surgery within a multimodal rehabilitation program. The objective is to correlate HRV indices with functional capacity, physiological reserve, and frailty during the prehabilitation phase.

Detailed Description

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The study evaluates HRV using the ANI monitor to determine adaptation to training load, optimize analgesic and anesthetic dosing, and predict postoperative complications. The HRV indices of Energy (SDNN) and ANI (HFnu) are monitored at two points: the initial pre-anesthesia consultation and one week before surgery. Results will be compared with the 6-minute walk test, MUST nutrition screening scale, and clinical frailty and FRAIL scales.

Conditions

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Frailty in Adult Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Patients who do not undergo prehabilitation.

Analgesia Nociception Index (ANI) Monitor

Intervention Type DEVICE

Non-invasive monitoring of HRV to evaluate autonomic nervous system activity using the indices of Energy (SDNN) and ANI (HFnu).

Prehabilitation

Patients who undergo trimodal prehabilitation including physical exercise, nutritional supplementation, and psychological support.

Analgesia Nociception Index (ANI) Monitor

Intervention Type DEVICE

Non-invasive monitoring of HRV to evaluate autonomic nervous system activity using the indices of Energy (SDNN) and ANI (HFnu).

Trimodal Prehabilitation

Intervention Type BEHAVIORAL

Program of physical exercise, nutritional supplementation, and psychological support according to the RICA guidelines of the Spanish Group for Multimodal Rehabilitation.

Interventions

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Analgesia Nociception Index (ANI) Monitor

Non-invasive monitoring of HRV to evaluate autonomic nervous system activity using the indices of Energy (SDNN) and ANI (HFnu).

Intervention Type DEVICE

Trimodal Prehabilitation

Program of physical exercise, nutritional supplementation, and psychological support according to the RICA guidelines of the Spanish Group for Multimodal Rehabilitation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age
* Scheduled for major adult surgery
* Any ASA classification
* Signed informed consent

Exclusion Criteria

* Urgent surgery
* Severe cognitive impairment
* Patient refusal to participate
* Pediatric patients
* Cardiac arrhythmia or atrial fibrillation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cristian Aragón-Benedí, M.D., Ph.D.,

Role: STUDY_CHAIR

Miguel Servet University Hospital

Locations

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Miguel Servet University Hospital

Zaragoza, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Cristian Aragón-Benedí, M.D., Ph.D.,

Role: CONTACT

+34625408866

Facility Contacts

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Cristian Aragón-Benedí

Role: primary

Other Identifiers

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PreANI001

Identifier Type: -

Identifier Source: org_study_id

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